BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC BI-POLAR 28X54MM

    MDR report key: 3953675 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06405
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." DEVICE STILL IMPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE RIGHT TOTAL HIP ARTHROPLASTY COMPONENT ON (B)(6) 2000. PATIENT ALLEGES THAT SUBSEQUENT RADIOGRAPHS REVEALED WEAR OF THE POLYETHYLENE PORTION OF THE ACETABULAR COMPONENT. A REVISION PROCEDURE IS ALLEGEDLY PLANNED TO REMOVE AND REPLACE THE ACETABULAR COMPONENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL SURGERY DATE AND INDICATES THAT A BI-POLAR ACETABULAR COMPONENT WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2000. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 ALLEGEDLY DUE TO PAIN, IMPLANT SQUEAKING, POLY WEAR AND AN ANTERIORLY ROTATED ACETABULAR CUP. THE ACETABULAR CUP, MODULAR HEAD AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430456 RINGLOC BI-POLAR 28X54MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 531780

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention